ABSTRACT

INTRODUCTION A large percentage of individuals with insomnia self-medicate with alcohol, over-the-counter (OTC) antihistamines, or complementary and alternative preparations (1,2). In the United States, the formulation and manufacture of OTC products are regulated by the U.S. Food and Drug Administration (FDA). Other products not requiring a prescription, such as dietary supplements, are unregulated. The National Center for Complementary Health and Alternative Medicine (NCCAM) at the National Institutes of Health (NIH) defines “complementary and alternative medicine (CAM)” as “practices that are unproven by science and not presently considered an integral part of conventional medicine” (3). CAM encompasses a variety of dietary supplements, herbal compounds, or formulations containing a mixture of these (4,5). Individuals seeking relief from insomnia may also combine two or more of any agents for insomnia (including prescription medications, OTC agents, alcohol, and CAM preparations) (6). Alcohol is the substance most commonly used to self-medicate for insomnia. Some 1.6 million noninstitutionalized adults with insomnia are estimated to use CAM to treat their insomnia or difficulties in sleeping (7); 20% of the population using herbals alone (8). The popularity of CAM in general is increasing; a 2007 national survey of adults and children found that 38.3% of U.S. adults using any CAM increased from 36% in 2002. Of those individuals using CAM in 2007, 1.4% of adults and 1.8% of children were doing so for insomnia. Nonvitamin, nonmineral products accounted for most (17%) CAM use (9).